EU medicines regulator backs Biogen ALS drug

Cambridge: Biogen Inc. has announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending a marketing authorization under exceptional circumstances for QALSODY (tofersen) for the treatment of adults with amyotrophic lateral sclerosis (ALS), associated with a mutation in the superoxide dismutase 1 (SOD1) gene.

“If authorized by the European Commission (EC), QALSODY will be the first treatment approved in the European Union to target a genetic cause of ALS, also known as motor neuron disease (MND),” the release stated.

“The CHMP’s positive opinion reinforces the impact QALSODY can have in SOD1-ALS and further demonstrates Biogen’s commitment to address the unmet needs of people living with ALS and neuromuscular diseases,” said Priya Singhal, M.D., M.P.H., Head of Development at Biogen. “We are proud to help pioneer the role of neurofilament in SOD1-ALS clinical trials and are deeply grateful to the people living with SOD1-ALS, their loved ones and study care teams for their dedication to furthering research for the ALS community.”

The CHMP’s recommendation for QALSODY is based on the totality of evidence, including the targeted mechanism of action, biomarker and clinical data. In the 28-week Phase 3 VALOR study, reductions of 60% in plasma neurofilament light chain (NfL) were observed in participants who received QALSODY compared to the placebo group, suggesting reduced neuronal injury. Trends towards improvement in the physical abilities of participants who received QALSODY were seen compared to those who received placebo, as measured by the ALS Functional Ratings Scale-Revised (ALSFRS-R). 

“The CHMP’s recommendation in support of QALSODY approval provides new hope for the ALS community in Europe,” said Philip Van Damme, M.D., Ph.D., professor of neurology and director of the Neuromuscular Reference Center at the University Hospital Leuven in Belgium. “This is a significant milestone for the entire ALS community – for the first time we have a treatment that led to sustained reductions in neurofilament, a marker of axonal injury and neurodegeneration. The QALSODY development program has provided critical learnings on clinical trial design and the use of biomarkers that is advancing the entire field.”

A marketing authorization under exceptional circumstances is recommended when the benefit/risk assessment is determined to be positive but due to the rarity of the disease, it is unlikely that comprehensive data can be obtained under normal conditions of use. The CHMP’s recommendation for QALSODY will now be reviewed by the EC for a decision on a marketing authorization in the European Union, with a decision expected in the second quarter of 2024.

Read also: Biogen, Eisai get Japanese nod for Leqembi Intravenous Infusion for Alzheimer’s Disease

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Register or face action: Medical Establishments in Telangana Get Ultimatum

Hyderabad: Issuing an ultimatum to the medical establishments, the Telangana Government authorities have asked them to ensure that they have proper registration.

In case they lack the requirement, the authorities have asked them to register or renew their registration in the next few days. Failing to do so, such medical establishments shall face action under the Clinical Establishments Act.

According to the concerned Act, all medical practitioners or centres must have a valid registration. In case, they do not have the registration, such facilities are considered to be illegal.

Also Read: Telangana Medical Council Continues Battle Against Quackery: 2 more FIRs Filed Against Unqualified Practitioners

As per the latest media report by the Times of India, one such ultimatum order was issued by the District Medical and Health Officer Suryapet. In the order, the DMHO asked all the nursing homes, clinics, hospitals, diagnostic centres, cathlabs, CT scan centres, X ray centres, dental clinics, physiotherapy and ultrasound centres to get their registration and renewals within three days.

Issuing a warning to take action for non-compliance, the order mentioned, “Any lapses, gaps and violations in registration and renewals will be viewed seriously.”

The daily adds that now that the vigil by the Drug Control Administration (DCA) and the Telangana State Medical Council (TSMC) has increased, genuine establishments, lacking the required registration, will get a chance to complete the paperwork.

Medical Dialogues had earlier reported that earlier this month TSMC filed an FIR against a quack at the Jubilee Hills police station after finding that the accused was running a clinic and prescribing allopathic medicines without the required qualifications (MBBS degree).

The complaint was filed by TSMC Vigilance Officer Sri M. Ramu, who has the responsibility to inspect and bring to the Council’s notice the irregularities and illegal practices in allopathic medicines.

Several other FIRs were later filed by the Council in its attempt to eradicate quackery in the State. Earlier, the Council had decided to launch an online database of registered doctors. As per the Council, this user-friendly registry would be accessible to the public, allowing individuals to easily verify the legitimacy of doctors before seeking their consultation.

With over 60,000 doctors enlisted in TSMC, the absence of digital records posed a challenge during council elections. Renewing registrations was particularly difficult as there was no online option available. In the absence of a streamlined process, TSMC introduced a portal during the recent elections, addressing concerns related to certification, renewals, NoCs for practising in other states, and more.

Meanwhile, recently, the Gujarat Government also decided to make it mandatory for all the medical establishments across the state to register themselves, irrespective of their size.

Also Read: Gujarat Clinical Establishments Act to be amended, Registration to become Mandatory for All hospitals

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PM Modi to inaugurate 250-bed IPD at AIIMS Rajkot on February 25

Ahmedabad: Prime Minister Narendra Modi will inaugurate Gujarat’s first All India Institute of Medical Sciences (AIIMS) in Rajkot built at a cost of Rs 1,195 crore on February 25. The Institute will begin admitting patients to its 250-bed Indoor patient department (IPD). 

This will be one of the five AIIMS to be dedicated to the nation by the prime minister from Rajkot on February 25, state Health Minister Rushikesh Patel said on Friday.

While the out-patient department (OPD) of the super-speciality hospital near Para Pipaliya village on the outskirts of Rajkot city is already operational, Modi will inaugurate the in-patient department (IPD), Patel told reporters in Gandhinagar.

Also Read:AIIMS Rajkot likely to be fully operational by October 2023

Modi laid the foundation stone for Rajkot AIIMS through video-conferencing in December 2020.

“Spread across 201 acres, Rajkot AIIMS is a world-class hospital with 720 beds, including ICU and super-speciality beds. On February 25, the prime minister will inaugurate 23 operation theatres, 30-bed AYUSH block and 250 beds of IPD. The remaining beds will be made available gradually,” Patel said.

The hospital was built at the cost of Rs 1,195 crore, he said, adding that the OPD has already served nearly 1.44 patients so far.

As per a government release, the prime minister will arrive at Rajkot AIIMS on Sunday afternoon and address a rally at the Race Course ground in the city later in the evening.

He will take part in a kilometre-long roadshow from the old airport to the venue of the public rally, it stated.

During the function, the prime minister will also virtually inaugurate four other newly-built AIIMS, located in Mangalagiri (Andhra Pradesh), Bathinda (Punjab), Rae Bareli (Uttar Pradesh), and Kalyani (West Bengal), Patel said.

The five super-speciality hospitals, including the one in Rajkot, have been built by the Centre at a cost of Rs 6,300 crore, he said.

Apart from this, Modi will inaugurate and perform ground-breaking for projects of Rs 48,000 crore of different state and Central departments, such as NHAI, Railways, Energy and Petrochemicals, Road and Building, Ports and Health and Family Welfare, the minister said.

Of these, projects of Rs 35,700 crore are for Gujarat, while the remaining are for other states, he said.

The prime minister will launch key projects, including power generation projects in Kutch, ground-breaking for the new Mundra Panipat crude-oil pipeline project, new cardiology hospital in Vadodara and doubling of the Rajkot-Surendranagar railway line, among others, Patel said.

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INI CET January 2024: AIIMS Nagpur notifies on Stray Vacancy Round, details

Nagpur- Through a notice, the All India Institute of Medical Sciences (AIIMS), Nagpur announced the date of the INI-CET stray vacancy round Counseling January 2024 session. Along with this, the seat matrix for 05 vacant seats in AIIMS, Nagpur has also been mentioned.

The INI-CET Stray round or Spot Counseling January 2024 session is scheduled to be held on Tuesday, February 27, 2024, at 9 AM on the Ground Floor, Admin Block, AIIMS, Nagpur.

Schedule of spot round of seat allotment in AIIMS Nagpur-

Reporting & submission of original certificates & verification

27.02.2024 (Tuesday) 09.00 AM to 10 AM

Announcement of Seat allocation of Spot Round

27.02.2024 (Tuesday) 11.00 AM

Physical Acceptance of allocated seat

On 27.02.2024 (Tuesday) from 11.00 AM to 01.00 PM

Provisional Joining of Course

On 27.02.2024 (Tuesday) before 04.00 PM

As per the seat matrix, there are total 05 vacant seats in 3 subjects among the UR, OBC, SC ST and EWS categories. There are 3 vacant seats in UR, 2 in OBC and no vacant seats in SC, ST and EWS.

PROCESS-

Eligible candidates who are interested in spot counselling need to register themselves online by 5 PM on 26 February 2024 through the link given in the notice. After registration, registered candidates should report to the venue by 09.00 am on 27th February 2024 with the required original documents. At the time of reporting, candidates are advised to carry one set of self-attested photocopies along with the original documents, which will be submitted during reporting.

DOCUMENTS-

1 Offer letter

2 Allocation letter

2 Registration slip

4 Admit card issued by AIIMS

5 Mark sheets of MBBS 1st,2nd and 3rd Professional Examinations.

6 MBBS Degree certificate

7 Internship Completion Certificate/Certificate from the Head of Institute or college that the candidate will be completing the internship by 31st January 2024.

8 Permanent/Provisional Registration Certificate issued by MCI or DCI/State Medical Council.

9 High School/Higher Secondary Certificate/Birth Certificate for proof of date of birth. (Matriculation)

Also, candidates will have to bring certificates if applicable-

1 SC/ST Certificate issued by the competent authority and should be in English or Hindi in language. The community should be mentioned in the certificate.

2 OBC/EWS Original Certificate issued by the competent authority for central Govt. jobs/for admission in central Govt. college/Institute. The sub-casts should tally with the central list of OBC/EWS. OBC/EWS Candidates should not belong to Creamy Layer. OBC/EWS certificate must be in the Central Govt. format as prescribed in the prospectus. The validity of OBC/EWS certification shall be as follows: – (i) The OBC (NCL) certificate should have been issued between 06.11.2022 to 05.11.2023 (date of exam) both dates inclusive. (ii) The EWS certificate must be valid for the financial year 2023-2024 and issued between 01.04.2023 to 05.11.2023 (on or before the date of the exam), both dates inclusive based on the income of the year 2022-2023

3 Physical Disability Certificate issued from a duly constituted and authorized Medical Board as mentioned in the prospectus.

PAYMENT-

The selected candidate needs to pay DD of Rs. 3027/- as a fee in the name of “Director AIIMS Nagpur”, payable at Nagpur.

SEAT MATRIX

S.NO

Subject

Total Seats

UR

OBC

SC

ST

EWS

1

ANATOMY

1

0

1

0

0

0

2

MICROBIOLOGY

3

2

1

0

0

0

3

PHYSIOLOGY

1

1

0

0

0

0

IMPORTANT POINT-

1 The Vacant seat under the reserve category will also be converted to the general pool and offered to candidates in the general merit list as per the rule of conversion.

2 The schedule and seat position are tentative and any change will be under the discretion of The Executive Director, AIIMS, Nagpur.

3 The selected candidate will have to undergo a medical examination on 28 February 2024 at AIIMS Nagpur.

4 All candidates who would be allocated a seat in the spot round are required to join the department latest by 04.00 PM on 29 February 2024.

To view the official notice, click the link below-

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India implementing largest digital programme for TB surveillance and monitoring

New Delhi: India has made ”significant progress” in scaling up molecular diagnostics and is implementing the largest digital programme for TB surveillance and monitoring, an official said during a convention for health writers in the national capital on Wednesday. 

Experts discussed the latest innovations, challenges and collaborative solutions in the fight against TB at the National Health Writers and Influencers Convention held at AIIMS, Delhi.

Even though tuberculosis (TB) is one of the leading causes of death and disability in India, affecting millions of people every year, doctors said the disease is “not a death sentence” and can be treated with proper treatment.

Dr Sanjay K Mattoo, additional deputy director general, Central TB Division, NTEP, Union Health Ministry gave an overview of the NTEP and its aims and challenges at the event. NTEP or National Tuberculosis Elimination Programme aims to end TB by 2025. 

Mattoo said India has made significant progress in scaling up molecular diagnostics, providing the most advanced medicines, and implementing the largest digital programme for TB surveillance and monitoring.

He also mentioned various collaborations and partnerships that the NTEP has forged with other ministries, such as labour, HRD, the railways, and with civil society and private sector organisations, to reach out to more TB patients and provide them with quality care and support.

He also cited the Aarogya Saathi app, which provides information and counselling to patients, and the Nikshay Poshan Yojana, which transfers money directly to the patients’ bank accounts as government initiatives that empower TB patients.

Healthcare experts, policymakers, researchers, and practitioners from the healthcare landscape attended the eighth edition of the event, organised by HEAL Foundation at AIIMS hospital.

Experts highlighted that there were still many gaps and barriers that hinder the effective diagnosis, treatment and prevention of TB, especially for drug-resistant TB (DRTB), which is harder to cure and more contagious.

Dr Rupak Singla, head of department of TB and chest disease, NITRD, highlighted the importance of early and accurate diagnosis of TB, the availability of new drug regimen, and the use of digital technology for TB management.

Singla also shared the experience of running a TB clinic, which is a unique model of online consultation and follow-up for patients with complex and resistant forms of TB. He said that this model has been replicated by neighbouring countries and has shown good results.

Citing the example of actor Amitabh Bachchan, who was cured of TB after taking medicines, he said that the disease was not a death sentence and can be cured with proper treatment.

Dr Vijay Hadda, additional professor, Pulmonary, Critical Care and Sleep Medicine, AIIMS, Delhi, focused on the social and environmental determinants of TB, such as poverty, illiteracy, malnutrition, and poor ventilation.

Hadda said since TB is a disease of the poor and the marginalised, addressing the social and economic factors that make people vulnerable to TB is also essential for its elimination.

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Not advising whole body PET scan not medical negligence: Consumer Court relief to Radiation Oncologist, Hospital

Nagpur: In a major respite to Jupiter Hospital and its Radiation Oncologist, the Nagpur Circuit Bench of the State Consumer Disputes Redressal Commission in Maharashtra has dismissed a complaint filed against them alleging gross medical negligence by not advising a whole-body PET scan, resulting in the unfortunate death of a cancer patient.

A Z Khwaja, Presiding Member, S D Wandhare, Member, K S Kapse, Member, while pronouncing the judgement clarified that the doctor carried out all necessary investigations in a prompt manner, and the complainants failed to establish that the doctor and the hospital had failed to exercise the standard care as was expected while giving treatment to the patient.

The case concerned the patient, who was referred to Jupiter Hospital for medical evaluation. She was diagnosed with stage II B Cancer by the Chief Oncologist on August 8, 2016. The prescribed treatment included 25 rounds of Radiotherapy, 5 sessions of Chemotherapy, and 4 sessions of Brachytherapy. However, the legal heirs of the patient claimed that the hospital failed to recommend a necessary Whole Body PET Scan at the initial stage for a comprehensive diagnosis. Despite undergoing the recommended treatment, the patient’s condition worsened, leading to further examinations elsewhere, including a whole-body bone scan, which revealed Skeletal Metastases. However, the patient eventually died on July 24, 2017.

Aggrieved, the heirs of the deceased moved the Commission alleging serious and gross medical negligence by the doctor and the hospital, arguing that the hospital failed to recommend a necessary Whole Body PET Scan at the initial stage, leading to a delayed detection of cancer in the spinal cord that eventually led to the patient’s death.

The complainants argued that the Hospital and the doctor displayed gross negligence from the initial diagnosis, failing to provide appropriate advice that could have potentially saved the life of the patient. Despite charging high fees, the Hospital allegedly did not fulfill its duty to safeguard the patient’s life. The complainants contended that due to misguided advice and improper treatment, they had to bear additional expenses of Rs 10,00,000. They alleged that although the patient was initially cured of cancer in her pelvic area, negligence by the doctors at Jupiter Hospital resulted in a delayed detection of cancer in the spinal cord. The doctor, serving as the Chief Radiation Oncologist at Jupiter Hospital, was accused of significant negligence, constituting a deficiency in service under Section 2(1)(g) of the Consumer Protection Act, 1986. The complainants claimed substantial financial, personal, and mental losses, seeking compensation of Rs 50,00,000 from Jupiter Hospital (O.P. No. 1) and the oncologist (O.P. No. 2).

In response, the hospital and the doctor vehemently contested the allegations, initiating a detailed legal proceeding.

Jupiter Hospital raised a preliminary objection, arguing that the State Consumer Commission in Nagpur lacked territorial jurisdiction to address the complaint. They contended that both Hospital and the oncologist conducted their business in Thane, not Nagpur, and invoked Section 17(2) of the Consumer Protection Act, 1986. Jupiter Hospital, a tertiary care hospital, asserted that it provided effective medical care and relief, emphasizing its comprehensive facilities, including a 350-bed hospital, a 24-hour Casualty Department, ICU, ICCU, and advanced diagnostic capabilities.

The hospital claimed that the patient was referred with a suspected diagnosis of carcinoma cervix stage IIA and received appropriate treatment, including radical concurrent radio-chemotherapy. The hospital denied any deficiency in services and argued that it acted in the patient’s best interest, providing the best possible medical care.

Jupiter Hospital disputed the necessity of a whole-body PET Scan and asserted that the complainants failed to establish medical negligence or deficiencies in service. They contended that the complaint lacked a cause of action as it was filed beyond the stipulated timeframe, suggesting an ulterior motive to extract money. Jupiter Hospital insisted that there was no negligence and deficiency in the services rendered, emphasizing its modern oncology unit managed by skilled oncologists. The burden to prove medical negligence, according to hospital, rested with the complainants, who allegedly failed to discharge this burden. The hospital further argued that the complainants were not entitled to monetary compensation, and their complaint, filed with unclean hands, lacked substance and should be dismissed with costs.

Meanwhile, the oncologist, submitted a separate written response challenging the complaint. Similar to Jupiter Hospital, the doctor raised objections to the complaint’s tenability, citing a lack of territorial jurisdiction among other grounds. The doctor acknowledged the patient was referred with a suspected diagnosis of carcinoma cervix stage II A by Dr. Ajgaonkar. He categorically denied examining the patient casually or routinely and asserted that thorough clinical examinations and necessary investigations were conducted following standard treatment protocols.

The oncologist contended that the clinical examination revealed the disease’s extension to the parametrium medially, later confirmed as Cancer Cervix FIGO stage IIB through histopathology and investigations. He denied any negligence in diagnosing the disease and claims to have discharged his duties responsibly and per standard protocols, with no medical negligence on his part. The oncologist argued that a whole-body PET scan is not mentioned as a mandatory investigation in medical literature at the initial diagnosis stage and is considered an optional investigation globally, aligning with Indian Council of Medical Research (ICMR) guidelines.

He maintained that the MRI of the abdomen and pelvis before treatment did not report lumbar bone metastasis, and no oncology doctor would recommend a PET scan when unnecessary. He asserted that he examined the patient based on the complaint of backache, emphasizing that the incidence of bone metastasis in carcinoma cervix cases is less than 5%. He points out that the patient’s complaint regarding the spread of the disease to the brain surfaced three months after discharge from Jupiter Hospital.

The doctor, emphasizing his qualifications and adherence to established techniques and protocols, administered radical radiation therapy with concurrent chemotherapy followed by brachytherapy for cancer cervix stage II B. He argued that cancer inherently can spread despite all precautions, and the mere spread does not imply negligence or deficiencies in services. He concluded that there was no medical negligence, gross negligence, and the complainants are not entitled to compensation. Instead, he suggested that the complaint alleging deficiencies in service should be dismissed with costs.

The complainant submitted an evidence affidavit, supported by various documents, including medical reports from Trupti Hospital and Jupiter Hospital, as well as bills detailing expenses related to the deceased’s treatment. Additionally, the complainant presented copies of income tax returns and the legal notice. In response, Jupiter Hospital, submitted an affidavit from Dr. Ankit Thakker, the Executive Director and CEO of Jupiter Hospital. Dr. Bhalavat, Radiation Oncologist, also submitted his affidavit and relied on several documents, including medical papers such as admission history, diabetic charts, medication sheets, and discharge summaries. The oncologist referenced the Consensus documents for the management of Cancer Cervix prepared by the Indian Council of Medical Research (ICMR). Both parties submitted written notes of arguments, and cited clinical practice guidelines in their defense.

After a thorough examination of the evidence, medical papers, and written arguments submitted by both the complainants and opposite parties, and after hearing the advocates, the only point for determination raised by the Commission was whether the complainants have proven that hospital and the oncologist committed medical negligence amounting to deficiency in service and unfair trade practices under the Consumer Protection Act, 1986. The findings indicated that the complainants did not establish such medical negligence.

The complainant’s advocate argued that there was gross medical negligence on the part of Jupiter Hospital and the oncologist during the treatment of the patient. The contention included claims that the patient’s continuous backache was not taken seriously, and the possibility of cancer spreading to other organs was not considered. The advocate emphasized the alleged negligence in not suggesting a whole body PET CT Scan to check for cancer spread, and the complainants lost their mother due to this negligence.

The advocate further contended that the oncologist, neglected the complaint of backache, did not follow standard protocols, and committed negligence by declaring the patient cancer-free in December 2017. The argument also mentioned the spreading of cancer from the backache to the brain, leading to the patient’s death.

The complainant sought to support these claims with various documents, including medical papers and reports. Additionally, the advocate referenced expert opinions, particularly one from Dr. Pathak, a Cancer specialist, although the opinion was considered vague and inconclusive.

In conclusion, the advocate asserted that gross medical negligence by the hospital and oncologist amounted to a deficiency in service under the Consumer Protection Act, 1986.

On the other hand, Dr Shenoy, the advocate representing Jupiter Hospital and Dr. Bhalavat strongly refuted and challenged the complainant’s contentions regarding medical negligence. While admitting that the patient was referred to Jupiter Hospital for cervical cancer, Dr Shenoy denied any negligence on the part of the hospital or the oncologist. He argued that standard treatment protocols were followed, as prescribed by the Indian Council of Medical Research (ICMR).

According to Dr Shenoy, the patient was already at an advanced stage (II B) when admitted, and immediate treatment, including chemotherapy and brachytherapy, was administered. He emphasized that the treatment was successful, citing reports indicating no visible residual disease and the patient being cancer-free from the cervix region.

The complainant’s main grievances, such as the alleged negligence in addressing backache and not recommending a whole-body PET Scan, were countered by Dr Shenoy. He contended that the patient’s late-stage arrival necessitated immediate treatment, making surgery impractical. Dr Shenoy pointed to medical literature and ICMR guidelines, stating that a whole-body PET Scan was optional and not mandatory.

He argued that the complainant failed to provide evidence supporting the necessity of a PET Scan over an MRI. He also highlighted the rapid development of metastasis and defended the decision not to order a PET Scan when the patient complained of backache. He claimed that the patient visited other doctors before coming to Jupiter Hospital, causing a delay in follow-up.

Regarding legal aspects, Dr Shenoy cited the Jacob Mathew case, stating that medical practitioners cannot be held negligent for choosing one procedure over another if it aligns with acceptable medical practices. He asserts that adherence to reasonable medical standards is sufficient, and the mere failure of treatment, even resulting in death, does not constitute negligence or deficiency in service.

During the proceedings, Sakina Daud, the advocate for the complainant, referenced several legal precedents, including the landmark case of Jacob Mathew Vs. State of Punjab, which provides guidelines on medical negligence. She also cited the case of Vinitha Ashok Vs. Lakshmi Hospital and others, where the Supreme Court emphasized that doctors would be liable for negligence if the professional opinion given was not reasonable or responsible. Additionally, Daud relied on the judgment in Rajv Gandhi Cancer Institute and Research Centre and others Vs. Lt. Col (Retd) Zile Singh Dahiya, where medical professionals were found liable for negligence in a cervical cancer case.

However, the Commission noted that these cases do not support the complainant’s arguments in the present matter. The facts in the cited cases differ significantly, and the Commission emphasized the distinctions. In the case before them, the evidence presented by Jupiter Hospital and Dr Bhalavat indicated prompt and appropriate investigations, addressing the patient’s advanced cancer stage (II B) upon arrival. The Commission underscored that the optional nature of whole body PET Scan was supported by evidence, and the complainant failed to demonstrate its mandatory requirement.

The Commission concluded that the complainant provided no material to establish the necessity of a PET Scan or prove negligence on the part of the Oncologist. The medical papers on record demonstrated adherence to standard protocols and treatments. Given these factors, the Commission found neither Jupiter Hospital nor the Oncologist can be held responsible for medical negligence in this case. It noted;

“…the complainant has not placed on record any material which could go to show that investigation with the help of whole body PET Scan was mandatory and was not optional and further that only whole body PET Scan could have detected spread of cancer in the bone or in the brain. Similarly, the complainant has also not placed on record any positive or unimpeachable material to show that Dr. *** Bhalavat (O.P.No. 2) had not exercised the degree of care which was expected from him as a Radiation Oncologist or that there was any negligence on his part. On the contrary medical papers placed on record go to show that Dr.  Bhalavat had not only carried out investigation as per standard mode laid down by the statutory body namely Indian Council of Medical Research (ICMR) but had also provided Radiation Therapy, Chemotherapy and Brachytherapy to the patient and patient was also discharged from the Jupiter Hospital after which there was a spread of cancer cells in other part of the body leading to death of the patient. But there is no material even to show that the patient reported immediately to Jupiter Hospital on detection of cancer cells in other part of the body. As such we feel that neither Jupiter Hospital(O.P.No.1) nor Dr. Bhalavat(O.P.No. 2) can be blamed for any negligence much less medical negligence.”

In the ongoing matter, the complainants had sought an expert opinion from Dr Pathak, a Cancer Specialist, regarding the treatment provided to the patient. Dr Anand Pathak’s report, submitted as part of the record, clarified that a PET CT Scan was only an optional investigation, along with other methods such as C.T. Scan, MRI, and ultrasound. Dr Pathak explicitly stated that the PET Scan was not deemed necessary, and he did not opine that it would have improved the patient’s survival. Instead, Dr Pathak affirmed that the patient had received appropriate treatment as per guidelines, noting the rapid progression of the disease.

The Commission, after a thorough examination of the evidence, concluded that the complainants failed to establish any lapses in the standard of care exercised by the Oncologist and Jupiter Hospital. There was no evidence supporting the contention that the spread of cancer to other parts of the body, specifically the bone, could have been detected earlier during patient’s admission in August 2016. Moreover, the complainants did not establish negligence in the decision not to perform a PET Scan, and thus, no medical negligence or deficiency in service is proven. It observed;

“Sum and substance of the entire discussion is that the complainants have failed to establish that Dr Bhalavat and Jupiter Hospital had failed to exercise the standard care as was expected while giving treatment to patient. The complainants have also failed to establish that the cancer which had spread in the other parts of the body namely bone could have been detected at the initial stage itself when the patient was admitted in Jupiter Hospital in the month of August-2016. The complainant has also failed to establish that both O.P.Nos. 1&2 were negligent in not carrying out the investigation by PET Scan thereby amounting to medical negligence or deficiency in service. As such complainants have failed to establish that there was any deficiency in service as well as unfair trade practice on the part of Jupiter Hospital ( O.P.No. 1) and Dr. Bhalavat (O.P.No. 2) and so we proceed to pass the following order. ..Complaint filed by the complainant Nos. 1 to 3 is hereby dismissed.”

To view the original order, click on the link below:

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AIIMS Announces Schedule of PG Professional Exams for MD, MS, MDS, Fellowship Programs, details

New Delhi- Through a recent notice, the All India Institute of Medical Sciences (AIIMS) released the schedule of postgraduate professional examinations for MD, MS, MDS and Fellowship programs.

As per the notice, the theory of postgraduate professional examinations for MD, MS, MDS and fellowship programs is scheduled from May 1 to 8 from 09:30 am to 12:30 pm. The exam will take place at the examination section, first floor, Convergence Block, AIIMS, New Delhi.

Schedule of the theory examinations-

THEORY EXAMINATIONS

Date

Day

Paper No.

Course

Venue & Time of Theory

01.05.2024

Wednesday

I

MD / MS / MDS

Examination Section First Floor

Convergence Block AIIMS, New Delhi

09:30 AM
to
12:30 PM

03.05.2024

Friday

II

– do –

06.05.2024

Monday

III

– do –

08.05.2024

Wednesday

IV

– do –

However, the date, time and venue of the practical exam and the practical, clinical and viva voce exams of the fellowship program have also not been decided yet. This will be decided later by the concerned department. As of now, a tentative date for the practical has been set i.e. between Monday, 13th, to 20 May 2024 (Monday). Meanwhile, the practical, clinical and viva examinations of the fellowship program are likely to be held between Wednesday, 08 to 15 May 2024.

However, the date, time, and location for the practical exam, as well as the practical, clinical, and viva voce exams for the fellowship program, have not yet been finalised. These will be decided later by the concerned department. Currently, a tentative date has been set for the practical examination and practical, clinical and viva voce examination. For practical, it is likely to be held between Monday, 13th, and Monday, 20th, May 2024 and the practical, clinical, and viva voce exams can likely take place between Wednesday, May 8th, and Wednesday, May 15th, 2024.

Furthermore, there will be no theory examination for the fellowship programme.

Lastly, candidates are advised to deposit their examination fee before the last date of registration which will be announced later and also take a printout of the admit card from the website.

No candidate will be allowed to enter the examination hall without an admit card and identity card.

Candidates are also urged to regularly visit the AIIMS Examination Section website “Student Tab” for all the latest information.

To view the official notice, click the link below-

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CDSCO Drug Alert: 46 Drug Samples Including Sun Pharma’s Levipil 500 Flagged

New Delhi: In its latest drug safety alert, the apex drug regulatory body, Central Drug Standard Control Organisation (CDSCO) has flagged 46 medicine batches for failing to qualify for a random drug sample test for January– 2024.

These include Moxifloxacin and Prednisolone Acetate Eye Drops (MOXIZEEP Eye Drops) manufactured by Zee Laboratories, Ondansetron Tablets IP 4 mg manufactured by Unicure India, Cefixime Oral Suspension IP 50mg/5ml manufactured by Ridley Life Science, Diclofenac Sodium Injection manufactured by ANG Lifesciences, Metronidazole Tablets IP 400 mg manufactured by Vivek Pharmachem, Trypsin, Bromelain and Rutoside Trihydrate Tablets manufactured by Pure and Cure Healthcare, Amoxycillin and Potassium Clavulanate Tablets IP 375 mg manufactured by Modern Laboratories and others.

Furthermore, the list of drug samples that are declared ‘Not Of Standard Quality’ includes Levetiracetam Tablets IP (Levipil 500) manufactured by Sun Pharma Laboratories, and Pantosec (Pantoprazole Tablets IP 40mg) manufactured by Hetero Labs.

This came after the analysis and tests conducted by the CDSCO Drugs Control Department on 932 samples. Of these, 886 samples were found to be of standard quality while 46 were declared Not of Standard Quality (NSQ).

A few of the reasons why the drug samples tested failed were the failure of the assay, failure of the dissolution test, failure of uniformity of weight, failure of clarity of solution and particulate matter, failure of pH, and description.

The samples collected were tested in four laboratories, RDTL Chandigarh, CDL Kolkata, CDTL Hyderabad, CDTL Mumbai, and RDTL- Guwahati.

List of Drugs, Medical Devices, Vaccine, and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of January– 2024

List of Drugs, Medical Devices, Vaccine and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of January– 2024

Total no. of samples received

– 846

Total number of samples tested

– 932

Total number of samples declared as of Standard Quality

– 886

Total number of samples declared as Not of Standard Quality

– 46

Total number of samples declared as Spurious

– 0

Total number of samples declared as Misbranded

– 0

S.No

Name of Drugs/medical device/cosmetics

Batch No.

Date of Manufacture

Date of Expiry

Manufactured By

Reason for failure

Drawn By (From

state/CDSCO Zone)

From (Name of Laboratory)

1

Chlorhexidine Gluconate Solution 4% w/v Surgical

Scrubbing

JDO-1027

05/2023

04/2025

Jpee Drugs, Plot No. – 53, Sector 6-A, SIDCUL,

Haridwar (Uttarakhand).

pH, weight per ml and Assay

CDSCO, East Zone, Kolkata

Central Drugs Laboratory, Kolkata

2

Glimepiride Tablets I.P. 1 mg

GLI10923

05/2023

04/2025

Karnataka Antibiotics & Pharmaceuticals Limited Arka The Business Centre, Plot No. 37, Site No. 34/4, NTTF Main Road, Peenya Industrial Area, 2nd Phase,

Bengaluru – 560 058, India.

Dissolution Glimepiride

of

CDSCO, East Zone, Kolkata

Central Drugs Laboratory, Kolkata

3

Levosalbutamol, Guaiphenesin & Ambroxol (Duvent- PD)

DPD030

01/12/2023

30/11/2026

Hygeia Pharmaceuticals MFG. (P) Ltd. 608, Dwarir Road Dhamaitala Dakshin Jagaddal, Pin- 700151

Assay/content of Levosalbutamol & Ambroxol Hydrochloride

CDSCO, East Zone, Kolkata

Central Drugs Laboratory, Kolkata

4

Amoxycillin and Potassium Clavulanate Tablets IP 375 mg

APCT2305

02/2023

01/2025

Modern Laboratories, 45- 47, Sector D-2, Industrial Area, Sanwer Road, Indore (M.P.) 452015,

India

Assay of

Amoxycillin, Clavulanic Acid & Dissolution of Amoxycillin, Clavulanic Acid

CDSCO, East Zone, Kolkata

Central Drugs Laboratory, Kolkata

5

Mesalazine Prolonged-release Tablets IP 1200 mg

UGT23128

01/2023

12/2024

Unimarck Healthcare Ltd., Plot No. 24, 25 & 37, Sector 6A, SIDCUL, Haridwar- 249403

(Uttarakhand).

Dissolution

CDSCO, East Zone, Kolkata

Central Drugs Laboratory, Kolkata

6

Vitamin A Oral Solution 100 ml

JDL-2921

06/2023

11/2024

Jpee Drugs, Plot No. – 53, Sector 6-A, SIDCUL,

Haridwar (Uttarakhand).

Microbial Enumeration

CDSCO, East Zone, Kolkata

Central Drugs Laboratory, Kolkata

7

Levosalbutamol, Ambroxol & Guaiphenesin Syrup (Bromex –

LS Expectorant)

BXE064

01/12/2023

30/11/2026

Hygeia Pharmaceuticals MFG. (P) Ltd. 608, Dwarir Road Dhamaitala Dakshin Jagaddal, Pin-

700151

Assay/content of ‘Levosalbutamol’

CDSCO, East Zone, Kolkata

Central Drugs Laboratory, Kolkata

8

Trypsin, Bromelain & Rutoside Trihydrate Tablets

PF8CC12

08/2023

07/2025

Pure & Cure Healthcare Pvt. Ltd., Plot No. 26A, 27-30, Sector- 8A, IIE,

SIDCUL, Ranipur, Distt. Haridwar – 249403, Uttarakhand.

Assay of ‘Trypsin’

CDSCO, East Zone, Kolkata

Central Drugs Laboratory, Kolkata

9

Levetiracetam Tablets IP (Levipil 500)

SIE1003A

04/2023

03/2025

Sun Pharma Laboratories Ltd., Plot No. 107-108, Namli Block, P.O.

Ranipool, Sikkim – 737 135

Dissolution

CDSCO (North Zone), Ghaziabad

Central Drugs Laboratory, Kolkata

10

Livocitra (Levocetirizine Hydrochloride Tablets I.P.)

AHT-23503

10/2023

09/2025

Aru Healthcare Pvt. Ltd., K-12, Industrial Area, Begrajpur, Muzaffarnagar

– 251 003

Dissolution

CDSCO (North Zone), Ghaziabad

Central Drugs Laboratory, Kolkata

11

Clindamycin Injection I.P. (Clindacin-300)

SAI-16589

11/2022

10/2024

Sunvet Healthcare, Village Shambhuwala, Paonta Road, Distt. Sirmour (H.P.) 173001

Description & Particulate Matter

Drugs Control Administration, Narasaraopet,

Andhra Pradesh

Central Drugs Laboratory, Kolkata

12

Amikacin Sulphate Injection I.P. (Amicin-100)

SVI-6964

11/2022

10/2024

Sunvet Healthcare, Village Shambhuwala, Paonta Road, Distt. Sirmour (H.P.) 173001

Description & Particulate Matter

Drugs Control Administration, Narasaraopet, Andhra

Pradesh

Central Drugs Laboratory, Kolkata

13

Fungal Diastase & Pepsin Syrup (NVZYME)

23RL0230

07/2023

12/2024

Regency Healthcare, 4KM Stone Kashipur Road, Danpur Rudrapur, Distt. U.S. Nagar, Uttarakhand

Assay of Fungal Diastase

Drugs Inspector, O/o CMO Bilaspur, Himachal Pradesh

Central Drugs Laboratory, Kolkata

14

Cyproheptadine HCl & Tricholine Citrate Syrup (Cypermed Syrup)

AQC2339A

03/2023

02/2025

Aquinnova Pharmaceuticals Plot No. 85, Ind. Area, Lodhimajra, Baddi, Distt. Solan – 174101 (H.P.)

Assay of

Tricholine Citrate

Drugs Inspector, O/o CMO Bilaspur, Himachal Pradesh

Central Drugs Laboratory, Kolkata

15

Moxifloxacin & Prednisolone Acetate Eye Drops (MOXIZEE-

P Eye Drops)

1223-51

02/2023

01/2025

Zee Laboratories Limited, Behind 47, Industrial Area, Paonta Sahib – 173025.

Assay of

Prednisolone Acetate

Drugs Inspector, Paonta Sahib,

Himachal Pradesh

Central Drugs Laboratory, Kolkata

16

Ceftriaxone Injection I.P. (DOXONE 1000)

JDI-3074

01/2023

12/2024

Jpee Drugs, Plot No. – 53, Sector 6-A, SIDCUL,

Haridwar (Uttarakhand).

Clarity of Solution, Particulate matter & Sterility

Drugs Inspector, Cuttack, Odisha

Central Drugs Laboratory, Kolkata

17

Absorbable Suture (Synthetic) USP Monolus Monofilament Poly (Glycolide-Co- Caprolactone)

Poliglecaprone-25

N190096AF

05/2019

04/2024

Lotus Surgicals Pvt. Ltd., Khasra No. 1051/1 & 2, Twin Industrial Estate, Selaqui, Dist. Dehradun, Pin 248197

(Uttarakhand), India.

Diameter

CDSCO, South Zone, Chennai

Central Drugs Laboratory, Kolkata

18

Surgical Tape (JMS Medi-Tape 300)

2022006

04/2022

03/2025

JMS Co. Ltd., 12-17

Kako-Machi, Naka-Ku, Hiroshima 730-82452, Japan

Length

CDSCO, West Zone, Mumbai

Central Drugs Laboratory, Kolkata

19

Surgical Tape (JMS Medi-Tape 310)

2022003

02/2022

01/2025

JMS Co. Ltd., 12-17

Kako-Machi, Naka-Ku, Hiroshima 730-8652, Japan

Length

CDSCO, West Zone, Mumbai

Central Drugs Laboratory, Kolkata

20

Surgical Tape (JMS Medi-Tape 320)

2022004

03/2022

02/2025

JMS Co. Ltd., 12-17

Kako-Machi, Naka-Ku, Hiroshima 730-8652,

Japan

Length

CDSCO, West Zone, Mumbai

Central Drugs

Laboratory, Kolkata

21

Surgical Tape (JMS Medi-Tape 330)

2022004

03/2022

02/2025

JMS Co. Ltd., 12-17

Kako-Machi, Naka-Ku, Hiroshima 730-8652, Japan

Length

CDSCO, West Zone, Mumbai

Central Drugs Laboratory, Kolkata

22

Bacillus Clausii Spores Suspension (LB LAC Oral Suspension)

AVA23I1

05/2023

04/2025

Allianz Biosciences Pvt. Ltd., 55/1, 2 & 3,

Whirlpool Road,

Thiruvandar Koil, Puducherry – 605102

Identification, Average Volume, Resistance to antibiotic, Presence of

Salmonella species & Assay

Drug & Food Control Organisation, Jammu & Kashmir

Central Drugs Laboratory, Kolkata

23

Metformin HCl Prolonged- Release & Glimepiride Tablets IP (Glimycare-M3

Forte)

T-230761

07/2023

06/2025

Vilin Bio Med Ltd., Unit-II, Khasra No. 85, Madhopur, Hazarathpur, Roorkee-247667, Uttarakhand.

Assay &

Uniformity of

Content of Glimepiride

CDSCO,

Rishikesh

Central Drugs Laboratory, Kolkata

24

Tranexamic Acid & Mefenamic Acid Tablets (Trancycle-MF)

DMT1127

01-Aug-2023

01-Jul-2025

DM Pharma Private Limited, Village Bhud, NH-21A, Baddi, District Solan (H.P.)

Assay

CDSCO,

Hyderabad

CDTL,

Hyderabad

25

Ambroxol Hydrochloride I.P.

Syrup (AMBROS)

GF296

Dec-2023

Nov-2025

Global Formulations, Plot No.7, P & T Colony, Medipally, Medchal Dist., Hyderabad-500098, T.S

Weight per ml

CDSCO,

Hyderabad

CDTL,

Hyderabad

26

Ambroxol HCl, Levosalbutomol Sulphate Guaiphenesin

Syrup (Brotex-LS)

GF.292

01-Dec-2023

30-Nov-

2025

Global Formulations, Plot No.7, P & T Colony, Medipally, Medchal- Malkajgiri Dist., –

5000098,

Weight per ml

CDSCO,

Hyderabad

CDTL,

Hyderabad

27

Terbutaline Sulphate, Ambroxol Hydrochloride, Guaiphenesin & Menthol Syrup

(Scoril)

GF-279

Nov-2023

Oct-2025

Global Formulations, Plot No.7, P & T Colony, Medipally, Medchal-

Malkajgiri Dist., Hyderabad-500098,

Weight per ml & Assay

CDSCO,

Hyderabad

CDTL,

Hyderabad

28

Folic Acid Tablets IP 5 mg

T112005

May-22

Apr-24

ANG LIFESCIENCES

INDIA LTD., Village Malkumajra, Nalagarh Road, Distt. Solan- 173205 (H.P.)

Description as the tablets are brittle & shows mottled appearance

CDSCO, West-

Zone, Mumbai

CDTL-

Mumbai

29

Bisacodyl Tablets

I.P. 5 mg

(Laxagen)

230754

Jul-23

Jun-26

Modi Antibiotics., Plot No, 28, G.I.D.C. Estate,

Odhav, Ahmedabad – 382415, (Guj).

Related Substances

CDSCO, West-

Zone, Mumbai

CDTL-

Mumbai

30

Metronidazole Tablets IP 400 mg

MZTJ23002

Jun-23

May-25

Vivek Pharmachem (India) Ltd., EPIP, Bari Brahmana, Jammu- 181

133

Description

CDSCO, West-

Zone, Mumbai

CDTL-

Mumbai

31

Pantosec (Pantoprazole Tablets IP 40mg)

PNS230422

Apr-23

Mar-25

Hetero Labs Limited (Unit-I), Kalyanpur (Village), Chakkan Road, Baddi (Tehsil), Solan

(Distt.), Himachal Pradesh – 173 205., India

Dissolution in Buffer stage

CDSCO, West-

Zone, Mumbai

CDTL-

Mumbai

32

Terbutaline, Bromhexine, Guaiphenesin and Menthol Syrup

(Terbo-Q Syrup)

LKM-38

Sep-2022

Aug-2024

Amkay Laboratories Pvt. Ltd., Preet Vihar, Nauchandi, Meerut.

Assay of

Bromhexine Hydrochloride

CDSCO (North Zone), Ghaziabad

RDTL,

Chandigarh

33

Levocetirizine Tablets IP

LVU-515

Jun-2023

May-2025

Healers Lab, Unit II, Plot No.33, H.P.S.I.D.C.,

Extn., Baddi, Distt. Solan (HP)

Identification and Assay of

Levocetirizine Hydrochloride

CDSCO (North Zone), Ghaziabad

RDTL,

Chandigarh

34

Glimepiride, Pioglitazone and Metformin (PR) Tablets (GLEM- GMP2 Tablets)

MPT-22149

Sep-2022

Aug-2024

Magnatek Enterprises, Plot No. 74 C (II) HPSIDC

Ind. Area Baddi, Distt. Solan (HP) 173205

Identification and Assay of

Pioglitazone Hydrochloride

calculated as Pioglitazone

O/o State Drugs Controller, H.Q. Baddi, Distt.

Solan, HP- 173205

RDTL,

Chandigarh

35

Calcium and Vitamin D3 Tablets I.P

UDT10704

Mar-2023

Aug-2024

Unicure India Ltd., C-21, 22 & 23, Sector-3, Noida-

201301, Distt. Gautam Budh Nagar (U. P.)

Description

Inspector of Drugs, Assam

RDTL,

Guwahati

36

Pantoprazole Gastro-Resistant Tablets I.P. (P40)

PFT23007MB

May-2023

Apr-2025

Sri Ram Healthcare Pvt. Ltd., Plot No. 81-C/2, EPIP Phase – I, Jharmajri, Baddi, Distt. – Solan, (H.P.) – 174 103.

Dissolution

Inspector of Drugs, Assam

RDTL,

Guwahati

37

Pantoprazole Sodium (EC) & Domperidone (SR) Capsules IP (Panzon-DSR)

BBC22550

May-2022

Apr-2024

Biomax Biotechnics (P) Ltd., 261, HSIIDC,

Industrial Estate, Alipur, Barwala134118 (Haryana)

Dissolution of Pantoprazole in acid stage & Description

Inspector of Drugs, Assam

RDTL,

Guwahati

38

GLIMEPIRIDE TABLETS I.P. 1

mg.

GLT-2301

Jan-2023

Dec-2024

Apple Formulations Pvt. Ltd,, Plot No.208, Kishanpur, Roorkee- 247667 (U.K)

Dissolution

Inspector of Drugs, Assam

RDTL,

Guwahati

39

COMPOUND SODIUM LACTATE INJECTION I.P. (RL)

03B3911

Jun-2023

May-2026

PASCHIM BANGA PHARMACEUTICAL,

NH-31, TIN MILE HAT, SONAPUR HAT, P.S.- CHOPRA, DIST : UTTAR

DINAJPUR, PIN – 733214 (W.B.)

Sterility Particulate Contamination and Description

Inspector of Drugs, Assam

RDTL,

Guwahati

40

Montelukast Sodium & Levocetirizine Hydrochloride Tablets IP.

(Folcet- MT)

FPT-2067

Oct-2022

Sep-2024

Forgo Pharmaceuticals., 27, DIC IND AREA,

Barotiwala, Teh: Baddi, Distt. Solan (HP) 174103

Assay/Content of Montelukast

Inspector of Drugs, Jharkhand

RDTL,

Guwahati

41

Montelukast Sodium & Levocetirizine Dihydrochloride Tablets IP..(Pevicet M

TABLETS)

AT22-0667A

Sep-2022

Aug-2024

ASPO PHARMACEUTICALS LLP., Plot No. 10,

HIMUDA Industrial Area, Phase-IV, Bhatoli Kalan, Baddi Distt. Solan (H.P.) 173205

Dissolution (Montelukast & Levocetirizine Dihydrochloride)

Inspector of Drugs, Bihar

RDTL,

Guwahati

42

Ondansetron Tablets IP 4 mg

SMT1006

Nov-2022

Oct-2024

Unicure India Ltd,, C-21, 22 & 23, Sector-3, Noida-

201 301, Distt. Gautam Budh Nagar (U.P.).

Dissolution

Inspector of Drugs, Bihar

RDTL,

Guwahati

43

Levocetirizine Dihydrochloride & Montelukast

Tablets (Tesact- M Tablets)

RT22464

Jul-2022

Jun-2024

RACHIL PHARMA, 18-

19, Phase-1, Ind. Area, Sansarpur Terrace, Distt : Kangra (H.P.) -176501.

Dissolution (Levocetirizine Dihydrochloride )

Inspector of Drugs, Jharkhand

RDTL,

Guwahati

44

Cefixime Oral Suspension IP 50mg/5ml

RD230004

Jan-2023

Dec-2024

Ridley Life Science Pvt. Ltd.,, D-1651, DSIDC,

Indl. Complex, Narela, Delhi- 110040

Assay of Cefixime

Inspector of Drugs, Meghalaya

RDTL,

Guwahati

45

Cefixime Oral Suspension IP 50mg/5ml

RD230003

Jan-2023

Dec-2024

Ridley Life Science Pvt. Ltd.,, D-1651, DSIDC,

Indl. Complex, Narela, Delhi- 110040

Assay of Cefixime

Inspector of Drugs, Meghalaya

RDTL,

Guwahati

46

Diclofenac Sodium Injection IP

I213108

Jul-2023

Jun-2025

ANG Lifesciences India Ltd., Village Malkumajra, Nalagarh Road, Baddi, Distt. Solan173205 (H.P.)

Particulate matter and Description

Inspector of Drugs, Assam

RDTL,

Guwahati

To view the official notice, click the link below:

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CDSCO Panel Grants Roche’s Protocol Amendment Proposal For Anti-cancer Drug Giredestrant

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the protocol amendment of the drug major Roche’s clinical study titled “A study evaluating the efficacy and safety of adjuvant Giredestrant compared with Physician’s choice endocrine monotherapy in participants with estrogen receptor-positive, HER2- Negative early breast cancer”.

This came after the drug major Roche presented protocol amendment version 5.0 dated 25 August 2023 protocol No. GO42784. This is a Phase III, global, randomized, open-label, multicenter, study evaluating the efficacy and safety of adjuvant giredestrant compared with endocrine therapy of physician’s choice in participants with medium- and high-risk Stage I-III histologically confirmed estrogen receptor (ER)-positive and human epidermal growth factor receptor 2 (HER2)-negative early breast cancer.

In addition, an open-label exploratory substudy will explore the safety and efficacy of giredestrant in combination with abemaciclib in a subset of the primary study population.

Giredestrant is an orally available selective estrogen receptor degrader/downregulator (SERD), with potential antineoplastic activity. Giredestrant induces an inactive conformation to the ER LBD, as measured by displacement of co-activator peptides.

Anastrozole is a type of hormone treatment. It works by lowering the levels of estrogen hormones in your body. It is mainly prescribed for women who have been through menopause and have a type of cancer called hormone-dependent breast cancer.

Exemestane is used to treat early and advanced breast cancer in women who have already stopped menstruating (postmenopausal). It is usually used in women who have already received a cancer medication called tamoxifen. Many breast cancer tumors grow in response to estrogen.

Letrozole is a medication that comes in tablet form. treats some types of breast cancer by decreasing the amount of estrogen hormone your body makes. This can slow or stop breast cancer cells from growing and spreading.

Tamoxifen is a selective estrogen receptor modulator (SERM) medication used to treat breast cancer in men and women and as a prophylactic agent against breast cancer in women.

At the recent SEC meeting for Oncology held on 7th and 8th February 2023, the expert panel reviewed the protocol amendment version 5.0 dated 25 August 2023 protocol No. GO42784.

After detailed deliberation, the committee recommended approval of the protocol amendment as presented by the firm.

Also Read: CDSCO Introduces Online Application System to issue Neutral Code for manufacturing Medical Devices for export

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UPSC Vacancies: Specialist Post In Various Specialties, Check All Details Here

New Delhi: The Union Public Service Commission (UPSC) has invited online applications for the Specialist Grade III Post in the Department of Health and Family Welfare, Government of National Capital Territory of Delhi permanently in different dept. 

UPSC is India’s premier central recruiting agency. It is responsible for appointments to and examinations for All India services and group A & group B of Central services.

UPSC Vacancy Details:

Total no. of Vacancies:- 54

The Vacancies are in the departments of Urology, Neurosurgery, Ophthalmology, Orthopaedics, ENT, Pulmonary Medicine,

Last Date of Application: 29th February 2024.

For more details about Qualifications, Age, Pay Allowance, and much more, click on the given link:

https://medicaljob.in/jobs.php?post_type=&job_tags=UPSC&location=&job_sector=all

HOW TO APPLY?

i) Candidates must apply online through the website http://www.upsconline.nic.in. Applications received through any other mode would not be accepted and summarily rejected.

ii) Candidates must upload the documents/certificates in support of all the claims made by them in the application like, Date of Birth, Experience (preferably in prescribed format), Desirable Qualification(s) etc. or any other information, separately against each claim in pdf file in such a way that the file size does not exceed 1 MB for the respective aforesaid modules and 2 MB for the “UPLOAD OTHER DOCUMENT” module and is legible when a printout taken. For that purpose, the applicant may scan the documents/certificates in 200 dpi grey scale. Documents like Pay Slip, Resume, Appointment Letter, Relieving Letter, Un-signed Experience Certificate etc. must not be uploaded in the Document Upload Module:-

a) Matriculation/10th Standard or equivalent certificate indicating date of birth, or mark sheet of Matriculation/10th Standard or equivalent issued by Central/State Board indicating Date of Birth in support of claim of age. Where date of birth is not available in certificate/mark sheets, issued by concerned Educational Boards, School leaving certificate indicating Date of Birth (in case of Tamil Nadu& Kerala).

b) Degree/Diploma certificate as proof of educational qualification claimed. In the absence of Degree/Diploma certificate, provisional certificate along with mark sheets pertaining to all the academic years.

c) Order/ letter in respect of equivalent Educational Qualifications claimed, indicating the Authority (with number and date) under which it has been so treated, in respect of equivalent clause in Essential Qualifications, if a candidate is claiming a particular qualification as equivalent qualification as per the requirement of advertisement.

d) Certificate(s) in the prescribed proforma from the Head(s) of Organization(s)/Department(s) for the entire experience claimed, clearly mentioning the duration of employment (date, month & year) indicating the basic pay and consolidated pay. The certificate(s) should also mention the nature of duties performed/experience obtained in the post(s) with duration(s). Experience Certificate should be issued in prescribed format relevant to the post. Experience certificate not in prescribed proforma but containing all the details as mentioned above would be considered on merits by the Commission.

e) Caste certificate by candidate seeking reservation as SC/ ST/ OBC, in the prescribed proforma from the competent authority indicating clearly the candidate’s Caste, the Act/ Order under which the Caste is recognized as SC/ ST/ OBC and the village/ town the candidate is ordinarily a resident of.

f) A declaration in the prescribed format by candidate seeking reservation as OBC, that he/she does not belong to the creamy layer on the crucial date, in addition to the community certificate (OBC). Unless specified otherwise, the prescribed closing date for receipt of Online Recruitment Application for the post is to be treated as crucial date.

g) Certificate of Disability in prescribed proforma issued by the competent authority to Persons with Benchmark Disabilities (PwBD) eligible for appointment to the post on the basis of prescribed standards of Medical Fitness. The Competent Authority to issue Certificate of Disability shall be a Medical Board duly constituted by the Central or a State Government. The Central/ State Government may constitute Medical Board(s) consisting of at least three members out of which at least one shall be a specialist in the particular field for assessing Locomotor/ Cerebral / Visual / Hearing disability, as the case may be.

h) Documentary support for any other claim(s) made.

Note: If any document/ certificate furnished is in a language other than Hindi or English, a transcript of the same duly attested by a Gazetted officer or notary is to be uploaded.

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